KR20220088421A - An inhaler article having an open distal end and an inhaler system - Google Patents

Abstract

The inhaler article 150 includes a body 151 extending from a mouthpiece end 154 to a distal end 156 along a longitudinal axis of the inhaler article, a capsule cavity 155 and a capsule 160 retained within the capsule cavity. do. The capsule cavity is defined within the body and is bordered downstream by a filter element 157 and upstream by a tubular element 153 defining a central passageway 152 in fluid communication with the capsule cavity. The central passageway defines an air inlet aperture extending from the distal end of the body toward the capsule cavity, the tubular element having a central passageway inner diameter ranging from about 50% to about 90% of the inner diameter of the capsule cavity. The inhaler article is configured to receive a vortex suction airflow into the central passageway.

Description

An inhaler article having an open distal end and an inhaler system

The present disclosure relates to an inhaler article and an inhaler system comprising a holder and an inhaler article. The inhaler article includes an open distal end to receive an inhalation airflow into the inhalation article during consumption.

Dry powder inhalers are not always completely suitable for delivering dry powder particles to the lungs at an inhalation rate or airflow rate that is within the inhalation rate or airflow rate of conventional smoking regimes. Dry powder inhalers may be complex to operate or may include moving parts. Dry powder inhalers often try to deliver an entire dry powder dose or capsule load in a single breath.

It would be desirable to provide an inhaler article that minimizes complexity and provides for high-speed assembly of the inhaler article. It would be desirable to provide an inhaler system that efficiently depletes a capsule of particles during consumption. It would be desirable to provide an inhaler article that receives a vortex intake airflow into the inhaler article. It would be desirable to provide an inhaler article that is substantially biodegradable. It would be desirable to provide an inhaler article formed from materials used in the manufacture of conventional cigarettes or smoking articles.

It would be desirable to provide a holder capable of activating and holding the inhaler article and delivering a vortex or rotating inhalation airflow to the inhaler article during consumption. It would be desirable to provide an inhaler system comprising a low profile and reusable holder for an inhaler article capable of activating the inhaler article. It would be desirable to provide a nicotine powder inhaler system that delivers nicotine particles to the lungs at an inhalation or airflow rate within a conventional smoking regime inhalation or airflow rate. It would also be desirable to deliver nicotine powder in an inhaler article having a shape similar to a conventional cigarette.

The present disclosure relates to an inhaler article. The inhaler article is configured to receive a swirling or rotating intake airflow during consumption. The inhaler article may receive a swirling or rotating intake airflow from a holder configured to induce a swirling intake airflow in the inhaler article during consumption. The holder and inhaler article may form an inhaler system from which the present disclosure is also directed.

According to one aspect of the present invention, an inhaler article includes a body extending from a mouthpiece end to a distal end along a longitudinal axis of the inhaler article, a capsule cavity and a capsule retained within the capsule cavity. The capsule cavity is defined within the body and is bordered downstream by a filter element and upstream by a tubular element defining a central passageway in fluid communication with the capsule cavity. The central passageway defines an air inlet aperture extending along the longitudinal axis of the inhaler article and from the distal end of the body towards the capsule cavity. The tubular element has a central passageway inner diameter ranging from about 50% to about 90% of the inner diameter of the capsule cavity. The capsule is disposed within the capsule cavity. The inhaler article is configured to receive a vortex suction airflow into the central passageway.

Advantageously, an inhaler article having an open distal end that receives a vortex or rotating intake airflow during consumption reduces the complexity of the inhaler article and allows such inhaler article to be assembled at high speed.

The tubular element extends from a first end defining an upstream boundary of the capsule cavity to a second opposite end defining a distal end of the inhaler article body.

The tubular element may have a central passage inner diameter that is less than the diameter of the capsule. The tubular element may have a central passageway inner diameter ranging from about 70% to about 90% of the inner diameter of the capsule cavity.

The tubular element may be formed of a cellulosic material. The tubular element may be formed from cellulose acetate. Tubular elements can be combined with thermoplastic starch-based plastics (TPS), polyhydroxyalkanoates (PHA), polylactic acid (PLA), polybutylene succinate (PBS), polycaprolactone (PCL), or hemp-based plastics. It can be formed of the same biodegradable resin. Preferably, the tubular element is formed from an extrusion grade biodegradable resin. Preferably, the tubular element is formed of a polylactic acid material.

Advantageously, the tubular element formed of a cellulosic material, or cellulose acetate, or polylactic acid material, is substantially biodegradable and can reduce the environmental impact of the inhaler article.

The membrane may be secured to the second opposite end of the tubular element. The membrane may include two or more slits or lines of weakness. The membrane may be in the shape of a disk. The membrane may be formed of a cellulosic material. The membrane may be formed of paper, cardboard or cardboard.

Advantageously, the membrane formed of the cellulosic material is substantially biodegradable and can reduce the environmental impact of the inhaler article. The membrane may provide a protective cover or sanitary barrier for the retained capsule and inhaler article prior to consumption of the inhaler article.

The wrapping layer may join the filter element, the capsule cavity, and the tubular element with a serial axial border. The lapping layer may be formed of a cellulosic material.

Advantageously, the wrapping layer formed of cellulosic material is substantially biodegradable and can reduce the environmental impact of the inhaler article. Coupling the inhaler article element with the wrapping layer provides for high-speed assembly of the inhaler article.

Capsules may contain pharmaceutically active particles. For example, the pharmaceutically active particle may comprise nicotine. The pharmaceutically active particles may have a mass median aerodynamic diameter of about 5 μm or less, or in the range of about 0.5 μm to about 4 μm, or in the range of about 1 μm to about 3 μm.

According to another aspect of the present invention, an inhaler system includes an inhaler article described herein, and a holder for the inhaler article, wherein the holder is configured to provide a swirling or rotating intake airflow to the inhaler article. The holder includes a housing defining a housing cavity.

Advantageously, incorporating the vortex generating element into the reusable holder can simplify construction of the inhaler article and reduce the complexity of the inhaler system. An inhaler article containing a vortex intake airflow is easier to manufacture and may have a simpler construction than an inhaler article that must induce a vortex intake airflow. A simpler inhaler article may also provide less environmental burden.

The holder may include a sleeve configured to retain the inhaler article within the housing cavity. The sleeve may include a sleeve cavity and be movable within the housing cavity along a longitudinal axis of the housing. The sleeve includes a first open end and a second opposite end. The second opposite end of the sleeve may be configured to allow air to enter the sleeve cavity. The second opposite end of the sleeve may include a sleeve tubular element extending into the sleeve cavity. The sleeve tubular element may extend into the tubular element of the inhaler article and be configured to secure the inhaler article within the sleeve.

The sleeve tubular element may define an upstream boundary of the capsule cavity when an inhaler article is received within the sleeve cavity.

The holder may further include a penetrating element secured to and extending from the holder housing inner surface. The piercing element may extend through a second opposite end of the sleeve along a longitudinal axis of the housing into the sleeve cavity and be configured to activate the capsule.

The second opposite end of the sleeve may be configured to induce a vortex or rotational airflow in the intake airflow entering the capsule cavity.

Advantageously, using a reusable holder to generate a rotating or swirling airflow may improve the uniform generation of a rotating or swirling airflow when provided to a consumer inhaler article. This rotating or swirling airflow may be provided to the capsule cavity of an inhaler article received within the sleeve of the holder. The rotating or vortex airflow induces the capsule contained within the capsule cavity to rotate the particles and release the particles into the rotating or vortex airflow to the consumer.

Advantageously, providing a feature on the second opposite end of the sleeve that engages the received inhaler article may improve a reliable airflow connection from the vortex inducing sleeve to the inhaler article received within the sleeve. The interference fit may also provide for secure engagement of the inhaler article received within the sleeve so that the inhaler article does not come off the sleeve or associated holder.

Advantageously, a reusable holder that induces a rotating or vortex airflow reduces the complexity of the associated consumable inhaler article. This may reduce the overall manufacturing cost of these inhaler systems, and may improve the reliability or efficiency of capsule particle depletion.

Advantageously, the inhaler system provides an inhaler system that minimizes moving parts. Advantageously, the inhaler system utilizes a separate holder that induces a rotating or swirling airflow in the inhaler article contained within the holder. This may allow the holder to be reusable and the inhaler article to be disposed of after a single use. Advantageously, the inhaler system efficiently delivers nicotine particles to the lungs at an inhalation or airflow rate that is within a conventional smoking regime inhalation or airflow rate. The inhaler delivers the nicotine powder into an inhaler article having a shape similar to a conventional cigarette. The inhaler systems described herein are capable of delivering dry powder to the lungs at an inhalation or airflow rate that is within the inhalation or airflow rate of a conventional smoking regime. The consumer may take a consumer inhalation or "puff", with each "puff" delivering a quantity of dry powder contained within a capsule contained within a capsule cavity. Such inhaler articles may have a shape similar to a conventional cigarette and may mimic conventional smoking. Such inhaler articles may be simple to manufacture and convenient for use by consumers.

Airflow management through the capsule cavity of the inhaler article may cause rotation of the capsule contained therein during inhalation and consumption. A capsule may contain particles comprising nicotine (also referred to as “nicotine powder” or “nicotine particles”) and optionally particles comprising flavor (also referred to as “flavour particles”). Rotation of the penetrating capsule may suspend and aerosolize the nicotine particles released from the penetrating capsule into the inhaled air moving through the inhaler article. The flavor particles can be larger than the nicotine particles and can help deliver the nicotine particles into the user's lungs, but the flavor particles preferably remain in or in the user's mouth. The nicotine particles and optionally flavor particles may be delivered with the inhaler article at an inhalation rate or airflow rate within the inhalation rate or airflow rate of a conventional smoking regime.

The term “nicotine” refers to nicotine and nicotine-inducing factors such as free-base nicotine, nicotine salts, and the like.

The term "flavor" or "flavor" refers to an organoleptic compound, composition, or material intended to modify and modify the taste or aroma properties of nicotine while it is consumed or inhaled.

The terms "upstream" and "downstream" refer to the relative positions of the described holder, inhaler article and elements of the inhaler system with respect to the direction of the inhalation airflow as the inhalation airflow is drawn upon the holder, the inhaler article and the body of the inhaler system.

The terms “proximal” and “distal” are used to describe the relative position of a holder, inhaler article, or component or portion of a component of a system. A holder or element (eg, a sleeve) forming a holder according to the present invention has, in use, a proximal end to receive an inhaler article and an opposed distal end, which may be a closed end, or an end closer to the proximal end of the holder. has An inhaler article according to the present invention has a proximal end. In use, the nicotine particles exit the proximal end of the inhaler article for delivery to the user. The inhaler article has a distal end opposite the proximal end. The proximal end of the inhaler article may be referred to as the mouth end.

An inhaler article may be combined with the holder to form an inhaler system. The holder is configured to provide a swirling or rotating suction airflow to the inhaler article. The holder also activates the inhaler article by piercing the capsule, thereby providing reliable activation of the capsule within the inhaler article (by puncturing the capsule with a penetrating element of the holder), releasing the particles contained within the capsule and releasing the article. Particles can be delivered to consumers. The holder is separate from the inhaler article, but the consumer can use both the inhaler article and the holder while consuming the particles released within the inhaler article. Consumer Such an inhaler article may be combined with a holder to form a system or kit. A single holder activates (pierces or pierces) the capsule contained within each inhaler article, and for each inhaler article of activation of the inhaler article, ten It can be used on more than, 25 or more, or 50 or more, or 100 or more inhaler articles.

The present disclosure relates to an inhaler article. The inhaler article is configured to receive a swirling or rotating intake airflow during consumption. The inhaler article may receive a swirling or rotating intake airflow from a holder configured to induce a swirling intake airflow in the inhaler article during consumption. The holder and inhaler article may form an inhaler system from which the present disclosure is also directed.

The inhaler article includes a body extending from a mouthpiece end to a distal end along a longitudinal axis of the inhaler article, a capsule cavity and a capsule retained within the capsule cavity. The capsule cavity is defined within the body and is bordered downstream by a filter element and upstream by a tubular element defining a central passageway in fluid communication with the capsule cavity. The central passageway defines an air inlet aperture extending from the distal end of the body towards the capsule cavity. The central passageway defines an air inlet aperture extending from the distal end of the body to the capsule cavity.

The inhaler article receives a swirling or rotating intake airflow at the air inlet aperture. The swirling or rotating inhalation airflow traverses the inhaler article from the distal end central passageway to the capsule cavity to the filter and out of the mouthpiece end of the inhaler article. The intake airflow preferably flows coincidentally with the longitudinal axis of the tubular element when flowing through it.

The inhaler article is configured to receive a vortex intake airflow directly into the distal end air inlet aperture of the inhaler article. The vortex suction airflow continues downstream into the capsule cavity and induces rotation of the capsule received or positioned within the capsule cavity. The activated capsule releases a dose of particles through the mouthpiece into a vortex suction air stream downstream to the consumer. Thus, a vortex intake airflow is created upstream from the inhaler article, the vortex intake airflow enters the distal or most upstream end of the inhaler article and is directed into the capsule cavity to rotate or pivot a capsule positioned within the capsule cavity.

The inhaler body may be similar in size and shape to a smoking article or cigarette. The inhaler body may have an elongate body extending along a longitudinal axis of the inhaler article. The inhaler body may have an outer diameter that is substantially uniform along the length of the elongate body. The inhaler body may have a circular cross-section that may be uniform along the length of the elongate body. The inhaler body may have an outer diameter in the range of from about 6 mm to about 10 mm, or from about 7 mm to about 10 mm, or from about 7 mm to about 9 mm, or from about 7 mm to 8 mm, or about 7.2 mm. The inhaler body may have a length (along the longitudinal axis) in the range of about 40 mm to about 80 mm, or about 40 mm to about 70 mm, or about 40 mm to about 50 mm, or about 45 mm.

A filter element located downstream of the capsule cavity may extend from the capsule cavity to the mouthpiece end of the inhaler article. The filter element may have a length ranging from about 10 mm to about 30 mm, preferably from about 15 mm to about 25 mm, more preferably from about 20 mm to about 22 mm.

The tubular element has an outer surface or diameter that contacts the body or forms a distal end of the inhaler article body. The intake air flows through the center of the tubular element along the central passageway of the tubular element. The tubular element may have a diameter substantially equal to the outer diameter of the inhaler article. The tubular element may have a diameter ranging from about 6 mm to about 9 mm or from about 6 mm to about 8 mm.

The tubular element is coaxial with the longitudinal axis of the inhaler article. The tubular element extends from a first end defining an upstream boundary of the capsule cavity to a second opposite end defining a distal end of the inhaler article body. The tubular element may have a uniform cross-section from a first end to a second opposite end of the tubular element.

The tubular element may have a thickness ranging from about 0.5 mm to about 1.5 mm, or from about 0.5 mm to about 1 mm. Preferably, the thickness of the tubular element is uniform from the first end to the second opposite end of the tubular element.

The open tubular element may have a length ranging from about 3 mm to about 12 mm, or from about 3 mm to about 7 mm or from about 4 mm to about 6 mm, or about 5 mm.

The tubular element may be formed of a biodegradable material. The tubular element may be formed of a fibrous material. The tubular element may be formed of a cellulosic material. The tubular element may be formed from cellulose acetate. Tubular elements can be combined with thermoplastic starch-based plastics (TPS), polyhydroxyalkanoates (PHA), polylactic acid (PLA), polybutylene succinate (PBS), polycaprolactone (PCL), or hemp-based plastics. It can be formed of the same biodegradable resin. Preferably, the tubular element is formed from an extrusion grade biodegradable resin. Preferably, the tubular element is formed of a polylactic acid material.

The tubular element may be formed of a cellulosic material. The tubular element may be formed from cellulose acetate. The tubular element may be formed of a polylactic acid material.

The tubular element defines a central passageway. The central aisle is an open empty space. The central passageway may define an open void (or open channel) from a first end to a second opposite end of the tubular element. The central passageway may provide fluid communication from a first end to a second opposing end of the tubular element. The central passage may be unobstructed.

The central passageway is coaxial with the longitudinal axis of the inhaler article. The central passageway may have a uniform cross-section from a first end to a second opposing end of the tubular element. The central passageway may have a diameter less than the diameter of the capsule. Accordingly, the capsule may not pass through the central passageway and remains within the capsule cavity.

The tubular element may have a central passageway inner diameter ranging from about 50% to about 90% of the inner diameter of the capsule cavity. The tubular element may have a central passageway inner diameter ranging from about 70% to about 90% of the inner diameter of the capsule cavity.

The central passageway may have a uniform internal or open diameter in the range of about 3 mm to about 6.5 mm, or from about 4 mm to about 6 mm, or from about 5 mm to about 6 mm or about 5.5 mm.

The central passageway may have a length in the range of about 3 mm to about 12 mm, or about 3 mm to about 7 mm or about 4 mm to about 6 mm, or about 5 mm.

The membrane may be secured to the second opposite end of the tubular element. The membrane may be attached to the second opposite end of the tubular element. The membrane may be attached to the second opposite end of the tubular element with an adhesive. The membrane may provide a barrier to reduce or prevent contaminants or foreign matter from entering the central passageway of the tubular element.

The membrane can easily rupture allowing intake air to enter the central passageway. The membrane may be ruptured or opened to expose substantially the entire open central passageway. The membrane may provide a protective cover or sanitary barrier for the retained capsule and inhaler article prior to consumption of the inhaler article.

The membrane may be deformable between a closed configuration and an open configuration. In the closed configuration, the membrane defines a closed boundary bordering the capsule cavity. In the open configuration, the deformable element defines an opening through which air can flow into the capsule cavity.

The membrane may be arranged to contact the holder such that upon insertion into the holder, the membrane deforms from a closed configuration to an open configuration. The term “deform” should be understood to mean that the shape of the membrane is changeable. Deformation of the membrane may include elastic deformation, and the membrane returns to its closed configuration when no force is applied thereto. Alternatively, deformation of the membrane may include a plastic deformation in which the membrane remains in an open configuration after application of a force.

The membrane may include two or more slits or lines of weakness. Two or more slits or lines of weakness may intersect each other. The two or more slits or lines of weakness may intersect the longitudinal axis of the tubular element. The membrane may include a hinged element that moves about a pivot such that the membrane moves between an open configuration and a closed configuration, or a consumer hinged element.

The membrane may be in the shape of a disk. The membrane may be formed of a biodegradable material. The membrane may be formed of a cellulosic material. The membrane may be formed of paper, cardboard or cardboard.

The wrapping layer may join the filter element, the capsule cavity, and the tubular element with a serial axial border. The lapping layer may be formed of a cellulosic material.

The capsule cavity may define a cylindrical space configured to contain the capsule (the capsule may have, for example, an elongated or circular cross-section). The capsule cavity may have a substantially uniform or uniform diameter along the length of the capsule cavity. The capsule cavity may have a fixed cavity length. The capsule cavity has a cavity inner diameter orthogonal to the longitudinal axis, and the capsule has a capsule outer diameter. The capsule cavity may be sized to contain an elongate capsule. The capsule cavity may have a substantially cylindrical or cylindrical cross-section along the length of the capsule cavity. The capsule cavity may have a uniform inner diameter. The capsule may have an outer diameter that is from about 80% to about 95% of the inner diameter of the capsule cavity. The configuration of the capsule cavity relative to the capsule may facilitate limited movement of the capsule during activation or penetration of the capsule.

The capsule cavity may be defined by an inhaler article tubular element. The tubular element may be coupled between and aligned with the filter element and the tubular element forming the distal end of the inhaler article. These elements may be associated with a wrapper. The open tubular element defining the capsule cavity may be formed from a biodegradable material such as cardboard or cardboard.

The configuration of the capsule cavity relative to the capsule may facilitate stable rotation of the capsule within the capsule cavity. The longitudinal axis of the capsule can be stably rotated coaxially with the longitudinal axis of the inhaler body during inhalation. The configuration of the capsule cavity relative to the capsule may facilitate rotation of the capsule with some vibration within the capsule cavity.

By stable rotation is meant the longitudinal axis of the inhaler body substantially parallel or coaxial with the axis of rotation of the capsule. Stable rotation may mean that there is no matrix of rotating capsules. Preferably, the longitudinal axis of the inhaler body may be substantially coplanar with the axis of rotation of the capsule. Stable rotation of the capsule may provide uniform entrainment of a portion of the nicotine particles from the capsule over 2 or more, or 5 or more, or 10 or more "puffs" or inhalations by the consumer.

The capsule may be sealed within the inhaler article prior to consumption. The inhaler article may be contained within a sealed or hermetically sealed container or bag. The inhaler article may include a membrane (closing the second opposed end of the tubular element) and one or more peelable or removable sealing layers to an air outlet or mouthpiece of the inhaler article.

The capsule may rotate about a longitudinal or central axis as air flows through the inhaler article. The capsule may be formed of an airtight material that may be pierced or pierced by a penetrating element that may be separated or engaged with the inhaler to form a single aperture. The capsule serves to keep contaminants away from the capsule, but may be formed of a metallic or polymeric material that can be pierced or pierced by a penetrating element prior to consumption of the nicotine particles in the capsule. The capsule may be formed of a polymeric material. The polymeric material may be hydroxypropylmethylcellulose (HPMC). Capsules may be size 1 to size 4 capsules, or size 3 capsules.

Capsules may contain pharmaceutically active particles. For example, the pharmaceutically active particle may comprise nicotine. The pharmaceutically active particles may have a mass median aerodynamic diameter of about 5 μm or less, or in the range of about 0.5 μm to about 4 μm, or in the range of about 1 μm to about 3 μm.

A capsule may contain nicotine particles comprising nicotine (also referred to as “nicotine powder” or “nicotine particles”) and optionally flavor-comprising particles (also referred to as “flavor particles”). The capsule may contain a predetermined amount of nicotine particles and optional flavor particles. A capsule may contain sufficient nicotine particles to provide at least two inhalations or “puffs”, or at least about 5 inhalations or “puffs”, or at least about 10 inhalations or “puffs”. A capsule may contain sufficient nicotine particles to provide from about 5 to about 50 inhalations or "puffs", or from about 10 to about 30 inhalations or "puffs". Each inhalation or "puff" delivers about 0.1 mg to about 3 mg of nicotine particles to the user's lungs, about 0.2 mg to about 2 mg nicotine particles to the user's lungs, or about 1 mg nicotine particles to the user can be delivered to the lungs of

The nicotine particles can have any useful nicotine concentration based on the particular formulation used. The nicotine particles contain at least about 1 wt% nicotine up to about 30 wt% nicotine, or about 2 wt% to about 25 wt% nicotine, or about 3 wt% to about 20 wt% nicotine, or about 4 wt% to about 15 wt% nicotine nicotine, or from about 5% to about 13% nicotine by weight. Preferably, from about 50 μg to about 150 μg of nicotine can be delivered to the user's lungs with each inhalation or “puff”.

The capsule may hold or contain at least about 5 mg of nicotine particles or at least about 10 mg of nicotine particles. The capsule may have or contain less than about 900 mg of nicotine particles, or less than about 300 mg of nicotine particles, or less than 150 mg of nicotine particles. The capsule may hold or contain from about 5 mg to about 300 mg of nicotine particles or from about 10 mg to about 200 mg of nicotine particles.

When the flavor particles are mixed or combined with the nicotine particles inside the capsule, the flavor particles may be present in an amount to provide the desired flavor in each inhalation or "puff" delivered to the user.

The nicotine particles may have any useful size distribution for inhalation delivery preferentially into the lungs of a user. The capsule may contain particles other than nicotine particles. Nicotine particles and other particles may form a powder system.

A capsule may hold or contain at least about 5 mg of dry powder (also referred to as a powder system) or at least about 10 mg of dry powder. A capsule may have or contain less than about 900 mg of dry powder, or less than about 300 mg of dry powder, or less than about 150 mg of dry powder. A capsule may hold or contain from about 5 mg to about 300 mg of dry powder, or from about 10 mg to about 200 mg of dry powder, or from about 25 mg to about 100 mg of dry powder.

The dry powder or powder system is at least about 40%, or at least about 60%, or at least about 40% by weight of the powder system comprised in nicotine particles having a particle size of about 5 μm or less, or in the range of about 1 μm to about 5 μm. It can have about 80%.

The particles comprising nicotine have a mass median aerodynamic diameter (mass) of no greater than about 5 μm, or in the range of about 0.5 μm to about 4 μm, or in the range of about 1 μm to about 3 μm, or in the range of about 1.5 μm to about 2.5 μm. central aerodynamic diameter). The mass median aerodynamic diameter is preferably measured with a cascade impactor.

The flavor-comprising particles may have a mass median aerodynamic diameter in the range of about 20 μm or greater, or about 50 μm or greater, or about 50 μm to about 200 μm, or about 50 μm to about 150 μm. The mass median aerodynamic diameter is preferably measured with a cascade impactor.

The dry powder may have an average diameter of about 60 μm or less, or in the range of about 1 μm to about 40 μm, or in the range of about 1.5 μm to about 25 μm. The average diameter means the average diameter per mass, preferably measured by laser diffraction, laser diffusion or electron microscopy.

The nicotine in the powder system or nicotine particles may be a pharmaceutically acceptable free base nicotine, or a nicotine salt or nicotine salt hydrate. Useful nicotine salts or nicotine salt hydrates are, for example, nicotine pyruvate, nicotine citrate, nicotine aspartate, nicotine lactate, nicotine bitartrate, nicotine salicylate, nicotine fumarate ( nicotine fumarate, nicotine mono-pyruvate, nicotine glutamate or nicotine hydrochloride. A compound that combines with nicotine to form a salt or salt hydrate may be selected based on its expected pharmacological effect.

The nicotine particles preferably contain amino acids. Preferably, the amino acid may be a leucine such as L-leucine. If an amino acid such as L-leucine is provided to the nicotine-containing particles, the adhesion of the nicotine-containing particles may be reduced and the attraction between the nicotine particles may be reduced, thereby reducing aggregation of the nicotine particles. Similarly, aggregation of the nicotine particles with the flavor particles may also be reduced as adhesion to the flavor-containing particles may be reduced. Thus, the powder system described herein can be a free flowing material, with a stable relative particle size of each powder component even when the nicotine particles and flavor particles are combined.

Preferably, the nicotine may be a surface modified nicotine salt when the nicotine salt particles comprise coating or composite particles. A preferred coating or composite material may be L-leucine. One particularly useful nicotine particle may be nicotine bitartrate with L-leucine.

The powder system may include a population of flavor particles. The flavor particles may have any useful size distribution for selective inhalation delivery into the mouth or buccal oral cavity of a user.

The powder system may have at least about 40%, or at least about 60%, or at least about 80%, by weight of the population of flavor particles of the powder system comprised in particles having a particle size of about 20 μm or greater. The powder system can have at least about 40%, at least about 60%, or at least about 80% by weight of the population of flavor particles of the powder system comprised in particles having a particle size of about 50 μm or greater. The powder system may have at least about 40%, or at least about 60%, or at least about 80% by weight of the population of flavor particles of the powder system comprised in particles having a particle size in the range of about 50 μm to about 150 μm. .

Particles comprising flavor may include compounds to reduce adhesion or surface energy and resulting agglomeration. The flavor particles may be surface modified with an adhesion reducing compound to form coated flavor particles. One preferred adhesion reducing compound may be magnesium stearate. Providing flavor particles to an adhesion reducing compound such as magnesium stearate, particularly coating the flavor compound, can reduce the adhesion of the flavor-containing particles and reduce the agglomeration of flavor particles by reducing the attraction between the flavor particles. have. Accordingly, agglomeration of flavor particles with nicotine particles may also be reduced. Accordingly, the powder system described herein can have a stable relative particle size of the particles comprising nicotine and particles comprising flavor even when nicotine particles and flavor particles are combined. The powder system may preferably be free flowing.

Conventional formulations for dry powder inhalation contain carrier particles that serve to increase the fluidization of the active particles, as the active particles may be too small to be affected by the simple airflow through the inhaler. The powder system may include carrier particles. Such carrier particles may be saccharides such as lactose or mannitol, which may have a particle size greater than about 50 μm. Carrier particles can be utilized to improve dosage uniformity by acting as a diluent or bulking agent within the formulation.

Powder systems used in conjunction with the nicotine powder delivery systems described herein may be carrier-free or substantially free of sugars such as lactose or mannitol. The absence of a carrier or substantially free of sugars such as lactose or mannitol may allow nicotine to be inhaled and delivered to the user's lungs at an inhalation rate or airflow rate similar to that of a typical smoking system.

The nicotine particles and flavor may be combined in a single capsule. As noted above, the nicotine particles and flavor can each have reduced adhesion, resulting in a stable particle formulation in which the particle size of each component does not substantially change when combined. Alternatively, the powder system comprises nicotine particles contained within a single capsule and flavor particles contained within a second capsule.

The nicotine particles and flavor particles may be combined in any useful relative amounts so that the flavor particles are detected by the user when consumed as nicotine particles. Preferably, the nicotine particles and flavor particles form at least about 90% or at least about 95% or at least about 99% or 100% by weight of the total weight of the powder system.

The inhaler and inhaler system are less complex and can have a simplified airflow path compared to conventional dry powder inhalers. Advantageously, rotation of the capsule inside the inhaler body can help aerosolize the nicotine powder or powder system and maintain the free flowing powder. Accordingly, inhaler articles may not require the elevated inhalation rates typically used by conventional inhalers to deliver the aforementioned nicotine particles deep into the lungs.

The inhaler article may use a flow rate of less than about 5 L/min or less than about 3 L/min or less than about 2 L/min or about 1.6 L/min. Preferably, the flow rate may range from about 1 L/min to about 3 L/min or from about 1.5 L/min to about 2.5 L/min. Preferably, the inhalation rate or flow rate may be similar to that of the Health Canada smoking regime (Health Canada smoking regime), ie about 1.6 L/min.

An inhaler system includes an inhaler article described herein, and a holder for the inhaler article, wherein the holder is configured to provide a swirling or rotating inhalation airflow to the inhaler article.

The holder may include a sleeve configured to retain the inhaler article within the housing cavity. The sleeve may include a sleeve cavity and be movable within the housing cavity along a longitudinal axis of the housing. The sleeve includes a first open end and a second opposite end. The second opposite end of the sleeve may be configured to allow air to enter the sleeve cavity. The second opposite end of the sleeve may include a sleeve tubular element extending into the sleeve cavity. The sleeve tubular element may extend into the tubular element of the inhaler article and be configured to secure the inhaler article within the sleeve.

The holder may further include a penetrating element secured to and extending from the housing interior surface. The piercing element may extend through a second opposite end of the sleeve along a longitudinal axis of the housing into the sleeve cavity and be configured to activate the capsule.

The second opposite end of the sleeve may be configured to induce a vortex or rotational airflow in the intake airflow entering the capsule cavity.

The method includes inserting an inhaler article into a sleeve of a holder for the inhaler article. The inhaler article includes a body, the body extending from a mouthpiece end to a distal end along an inhaler longitudinal axis, a body length, and a capsule disposed within the inhaler article body. Then move the inhaler article and sleeve towards the piercing element until the piercing element pierces the capsule. Air is then drawn into the second opposite end of the sleeve of the holder to form a vortex intake airflow. This vortex intake airflow is then transferred into the inhaler article while the inhaler article is placed in the holder for the inhaler device. The spent inhaler article can then be removed from the holder and discarded. A new inhaler article may then be inserted into the holder and the method repeated.

The inhaler article is configured to receive a vortex intake airflow directly into the distal end of the inhaler article. The vortex suction airflow then continues downstream into the capsule cavity and induces rotation of the capsule contained within the capsule cavity. The activated capsule then releases a dose of the particles through the mouthpiece into a vortex suction air stream downstream to the consumer. The distal end or the most upstream end of the inhaler article includes an open aperture defining an open central passageway of the open tubular element. Thus, a vortex intake airflow is created upstream from the inhaler article, and the vortex intake airflow enters the distal end or the most upstream end of the inhaler article.

A holder for an inhaler article includes a housing including a housing cavity for receiving the inhaler article and a sleeve configured to retain the inhaler article within the housing cavity. The sleeve includes a sleeve cavity movable within the housing cavity along a longitudinal axis of the housing. The sleeve includes a first open end and a second opposite end. The second opposite end of the sleeve is configured to allow air to enter the sleeve cavity. The second opposite end of the sleeve is configured to induce a vortex on the air entering the sleeve cavity.

A second opposite end of the sleeve defines a vortex generating element configured to generate a vortex or rotating intake airflow. This vortex or rotating inhalation airflow can be delivered into the inhaler article to rotate the capsule and release the dry powder contained within the capsule.

A second opposite end of the sleeve includes a sleeve tubular element having a central passageway in fluid communication with the sleeve cavity. The second opposite end of the sleeve has at least one air inlet that allows air to enter into the central passageway. The at least one air inlet extends in a direction tangential to the central passageway. The second opposite end of the sleeve may have at least two air inlets that allow air to enter into the central passageway. The at least two air inlets extend in a direction tangential to the central passageway. The second opposite end of the sleeve may have at least three air inlets that allow air to enter into the central passageway. At least three air inlets extend in a direction tangential to the central passageway. The second opposite end of the sleeve may have four air inlets that allow air to enter into the central passageway. The four air inlets extend in a direction tangential to the central passage.

The sleeve tubular element may be coaxial with the longitudinal axis of the housing. The sleeve tubular element may be coaxial with the sleeve cavity. The sleeve tubular element may be coaxial with both the longitudinal axis of the housing and the sleeve cavity.

A sleeve tubular element having a central passageway may have a diameter in a range from about 30% to about 70% of the diameter of the sleeve cavity. A sleeve tubular element having a central passageway may have a diameter in a range from about 40% to about 60% of the diameter of the sleeve cavity.

A sleeve tubular element having a central passageway extends into the sleeve cavity and may form an annular recess with the sleeve cavity configured to receive a distal end of an inhaler article. A sleeve tubular element having a central passageway extends into the sleeve cavity and may form an annular recess with the sleeve cavity configured to retain the distal end of the inhaler article.

A sleeve tubular element having a central passageway may extend into a distal end of an inhaler article received within the sleeve cavity. The annular recess may be configured to hold the distal end of the inhaler article with an interference fit.

A sleeve tubular element having a central passageway may extend into the tubular element of an inhaler article received within the sleeve cavity. A sleeve tubular element having a central passageway may extend into a distal end central passageway of an inhaler article received within the sleeve cavity.

A sleeve tubular element having a central passageway may rupture, penetrate, or open a membrane sealing or blocking the central passageway of the inhaler article tubular element. A portion of the ruptured membrane may be forced onto a surface defining a central passageway of the inhaler article tubular element. Preferably, the sleeve tubular element having a central passageway exposes the full diameter of the central passageway of the inhaler article tubular element when inserted into the central passageway of the inhaler article tubular element.

At least a portion of the sleeve tubular element having the central passageway is located upstream from an inhaler article received within the sleeve. The sleeve tubular element with the central passageway is preferably coaxial with the longitudinal axis of the received inhaler article.

A sleeve tubular element having a central passageway may be sized to engage an inhaler article distal end tubular element defining a central passageway. A sleeve tubular element having a central passageway may abut an inhaler article distal end tubular element defining a central passageway. A sleeve tubular element having a central passageway may cooperate with an inhaler article distal end tubular element defining a central passageway. A sleeve tubular element having a central passageway may fit within an inhaler article distal end tubular element defining a central passageway. The sleeve tubular element central passage may have an inner diameter in the range of about 3 mm to about 5 mm, or about 4 mm.

A sleeve tubular element having a central passageway may include at least one air inlet extending in a direction tangential to the central passageway. The sleeve tubular element may include at least two air inlets extending tangentially to the central passageway. The sleeve tubular element may include at least three air inlets extending tangentially to the central passageway.

One or more air inlets may extend through a sidewall defining an opposing second end of the sleeve. The one or more air inlets may extend in a direction orthogonal to the longitudinal axis of the sleeve or housing. The one or more air inlets may extend in a direction orthogonal to the longitudinal axis of the sleeve tubular element having the central passageway.

A sleeve tubular element having a central passageway may comprise one air inlet extending in a direction tangential to the central passageway. A sleeve tubular element having a central passageway may include two air inlets extending tangentially to the central passageway. A sleeve tubular element having a central passageway may include three air inlets extending tangentially to the central passageway. A sleeve tubular element having a central passageway may include four air inlets extending tangentially to the central passageway.

Preferably, the at least one air inlet enters the central passageway of the sleeve tubular element at an inner diameter of the sleeve tubular element defining a perimeter or an inner diameter of the central passageway. Preferably, the at least two air inlets enter the central passage at an inner diameter of the central passage or an inner diameter of the sleeve tubular element defining a perimeter. Preferably, at least three air inlets enter the central passage at an inner diameter of the central passage or an inner diameter of the sleeve tubular element defining a perimeter of the central passage. Preferably, the four air inlets enter the central passage at the inner diameter of the sleeve tubular element defining the perimeter or the inner diameter of the central passage.

The two or more air inlets are preferably equally spaced from each other around the circumference of the central passageway of the sleeve tubular element.

At least one air inlet extending tangentially to the central passageway of the sleeve tubular element enters the central passageway adjacent an end surface defining a distal end of the sleeve. The end surface forms a substantially closed end surface such that only the penetrating element can extend through the end surface. The end surface extends perpendicular to the longitudinal axis of the sleeve. The end surface prevents intake air from flowing out through the distal end of the sleeve. The end surface directs intake air towards the sleeve cavity.

Preferably, at least one air inlet extending in a direction tangential to the central passageway of the sleeve tubular element enters the sleeve tubular element having the central passageway at the end surface. Improved capsule depletion occurs when the tangential air inlet is positioned closer to the end surface of the central passageway.

The sleeve tubular element may be of unitary construction with the sleeve (integrated with the sleeve) configured to retain the inhaler article within the housing cavity. The sleeve tubular element may form part of a second opposite end of the sleeve. The sleeve tubular element and sleeve may be formed by an injection molding process. The sleeve tubular element and the sleeve can be formed simultaneously in an injection molding process.

A sleeve tubular element having a central passageway may extend or project into the sleeve cavity. Such a sleeve tubular element having a central passageway may have an outer surface having an outer diameter facing the inner surface of the sleeve. An inner surface of the sleeve defines a sleeve cavity.

A sleeve tubular element having a central passageway may extend into the sleeve cavity for a distance ranging from about 2 mm to about 10 mm, or from about 3 mm to about 7 mm, or from about 4 mm to about 6 mm, or about 5 mm. In these and other embodiments, the sleeve tubular element having a central passageway has an outer diameter in the range of about 4 to about 6.5 mm or about 5 mm to about 6 mm, or about 5 mm to about 5.5 mm, or preferably about 5.25 mm. can have At least a portion of the sleeve tubular element having the central passageway may be inserted into the received inhaler article. Preferably, at least 50% of the sleeve tubular element having the central passageway is insertable into the contained inhaler article.

A sleeve tubular element having a central passageway extending into the sleeve cavity may form an annular recess with the sleeve cavity configured to receive a distal end of an inhaler article. A sleeve tubular element having a central passageway extending into the sleeve cavity may form an annular projection with the sleeve cavity configured to be received by a distal end of an inhaler article. A sleeve tubular element having a central passageway extending into the sleeve cavity may define both an annular recess and an annular projection within the sleeve cavity configured to receive a distal end of an inhaler article.

The distal end of the inhaler article may be configured to engage an annular recess formed by a sleeve tubular element having a central passageway extending into the sleeve cavity. The distal end of the inhaler article may be configured to engage an annular projection formed by a sleeve tubular element having a central passageway extending into the sleeve cavity. The distal end of the inhaler article may be configured to engage an annular projection and an annular recess formed by a sleeve tubular element having a central passageway extending into the sleeve cavity. A sleeve tubular element having a central passageway may be configured to extend into a distal end of an inhaler article received within the sleeve cavity.

The annular projection formed by the sleeve tubular element having a central passageway extending into the sleeve cavity may fit within or slide into the received inhaler article distal end tubular element. An annular projection formed by the sleeve tubular element having a central passageway extending into the sleeve cavity may fit within the inhaler article distal end tubular element. The annular projection formed by the sleeve tubular element having a central passageway extending into the sleeve cavity may form an interference fit within the inhaler article distal end tubular element. Accordingly, the central passageway of the sleeve tubular element having the central passageway may fit within the inhaler article distal end tubular element having the central passageway.

A holder for an inhaler article may include a penetrating element configured to pierce or activate a capsule within the inhaler article. The penetrating element may be secured to and extend from the housing inner surface. The penetrating element may be configured to extend through an end surface of the second opposed surface of the sleeve and into the sleeve cavity along a longitudinal axis of the housing.

The penetrating element may extend through an aperture in an end surface of the sleeve. The penetrating element may extend through the resealable element in the end surface of the sleeve. The resealable element may form a hermetic seal or barrier along the end surface of the sleeve when the penetrating element is not within the resealable element. The penetrating element may extend through the aperture in the end surface of the sleeve and substantially block airflow taking into account the aperture.

The penetrating element may pass through the end surface and puncture the capsule within the capsule cavity. If the resealable element is present in the through aperture, it may be resealable once the penetrating element is retracted or removed from the resealable element. The resealable element or membrane may include an element such as a septum. The resealable element or membrane may be formed from an elastic material such as rubber, silicone, metal foil co-laminated with a polymer, or latex or the like, or a cellulose acetate tow such as a high density cellulose acetate tow.

The penetrating element is secured to the housing inner surface and may extend from the housing inner surface along the penetrating element longitudinal axis into the housing cavity the length of the penetrating element. The penetrating element may be recessed by a recessed distance from the open proximal end of the housing.

The distal end and the most upstream end of the inhaler article may contact a second opposite end of the sleeve and force the sleeve to move toward the piercing element. The sleeve may be coaxial with the penetrating element. The sleeve may align the inhaler article such that the penetrating element reliably activates the capsule within the inhaler article. The sleeve or holder may also mechanically hold the penetrating element and support the penetrating element to prevent or mitigate deflection of the penetrating element.

The sleeve may define a first air inlet region including at least one air aperture through the sleeve. The first air inlet zone may include at least 2, at least 3, at least 4, or from about 1 to about 10 air apertures, or from about 3 to about 9 air apertures. The first air inlet region proximates the first open end of the sleeve. The first air inlet region is configured to allow air to flow into an airflow channel formed between the sleeve and the housing.

The sleeve can include a second air inlet section downstream from the first air inlet section. The second air inlet region includes a second opposite end of the sleeve configured to allow air to enter the sleeve cavity. The second air inlet section includes one, two or more, three or more, or four or more of inlet or intake air directly into a second opposed end of the sleeve at a tangent to the sleeve tubular element central passageway to form a vortex intake airflow. It may include an air aperture.

The holder may include a retaining ring element secured to the open proximal end of the housing. The retaining ring element retains the sleeve within the inhaler article cavity. The retaining ring has a thickness sufficient to stop or retain movement of the sleeve within the inhaler article cavity of the holder.

The holder may include a spring element configured to bias the sleeve between a relaxed and compressed (or unstrained) state or away from the penetrating element towards the open proximal end of the housing. A spring element is contained within the housing cavity of the holder and can be compressed as the movable sleeve and inhaler article move toward the piercing element. A spring element may be positioned between the sleeve and the closed end of the housing and contact the sleeve and the closed end of the housing. A spring element may be arranged around the piercing element. The spring element may be coaxial with the penetrating element. The spring element may be a conical spring.

The spring element may be secured to the distal end or closed relative to the holder. A spring element may be secured to the second opposite end of the sleeve. The spring element may be secured to both the closed end of the holder and the second opposite end of the sleeve. The spring element may be a conical spring. The conical spring may advantageously provide a low profile design to provide a more flexible design and a smaller overall compression thickness. The provision of a conical spring may also advantageously reduce the likelihood that the spring will bend when compressed compared to a cylindrical spring.

When the piercing element activates the inhaler article, the spring element biases the inhaler article away from the piercing element and away from the piercing element. A spring element may be disposed around the piercing element. The spring element may be coaxial with the penetrating element. The penetrating element may extend past the spring element when the spring element is in the relaxed position. The piercing element may extend past the spring element when the spring element is in a compressed position. The penetrating element may extend past the spring element when the spring element is in both a relaxed position and a compressed position. The penetrating element may extend past the spring element as the sleeve compresses the spring element.

The sleeve may include an elongate slot extending along a longitudinal length of the sleeve. When the sleeve includes the elongate slot, the housing may further include an alignment pin extending from the interior surface of the housing cavity. The alignment pin may be configured to mate with the elongate slot. Advantageously, the elongate slots and alignment pins provide a reliable path of travel between the relaxed and compressed positions.

The holder may include a marking element extending into the inhaler article cavity. The marking element may be configured to mark a surface of the inhaler article. The marking element may extend orthogonal to the holder or inhaler article longitudinal axis. The marking element may be configured to mark the exterior surface of the inhaler article in a mechanical manner. For example, the marking element may be configured to scratch, cut, rub, engrave, fold, or bend the outer surface of the inhaler article. The marking element may have a sharp end configured to scrape the inhaler exterior surface when received within the inhaler article cavity. The marking element may apply a color to the exterior surface of the inhaler when received within the inhaler article cavity. The marking element may mark the exterior surface of the inhaler when the penetrating element pierces a capsule disposed within the inhaler article. Accordingly, it indicates that the inhaler article has been activated and can be consumed by the user. This may also advantageously prevent the user from trying to reuse an inhaler article that has already been previously activated.

The marking element may extend orthogonal to the holder or inhaler article longitudinal axis. The marking element may be formed of a rigid material configured to provide a visual indication that the marking element has contacted the exterior surface of the inhaler. The marking element may be fixed to the holder housing. The marking element may form an alignment pin, as described above.

The marking element may extend through at least a portion of the thickness of the holder. The marking element may extend through the sleeve. The marking element may extend into the inhaler article cavity and into the sleeve. The marking element may extend at least a marking distance beyond the sleeve such that the marking element contacts the inhaler exterior surface when the inhaler article is received within the inhaler article cavity. The marking element may align with and mate with the elongate slot of the sleeve.

The penetrating element may be recessed by any suitable recessed distance from the open proximal end. For example, the piercing element may be separated from the open proximal end by a concave distance of at least about 10%, at least about 20%, at least about 25%, or at least about 30%, or at least about 35%, or at least about 40% of the length of the housing. can be concave. The penetrating element may extend from the open proximal end by a concave distance in the range of about 5% to about 50%, or about 10% to about 40%, or about 15% to about 40%, or about 20% to about 40% of the length of the housing. can be concave.

The penetrating element length may be any suitable length for the housing length. For example, the piercing element length may be from about 25% to about 60%, or from about 30% to about 50% of the length of the housing. The distal end of the piercing element may be secured to the distal end at or adjacent to the distal end of the housing. The entire length of the penetrating element may be co-spaced within the length of the housing.

The penetrating element is formed of a rigid material. The rigid material is sufficiently rigid to penetrate, puncture, or activate a capsule contained within the inhaler article. The penetrating element may be formed of metal. The penetrating element may be formed of, for example, stainless steel, such as 316 stainless steel. The penetrating element may be formed of a polymeric material. The penetrating element may be formed of a fiber-reinforced polymer material.

The housing may be formed of any rigid material. The housing may be formed of a polymeric material. Polymeric materials useful for forming the housing include polycarbonate, polypropylene, polyethylene, nylon, acrylonitrile butadiene styrene, styrene acrylonitrile, polyacrylate, polystyrene, PBT polyester, PET polyester, polyoxymethylene, polysulfone. , polyethersulfone, polyetheretherketone, or liquid crystal polymer.

The inhaler article may be received into the holder such that the inhaler article outer surface and the holder housing outer surface are concentric. When the inhaler article is received in the holder, the piercing element longitudinal axis may be coaxial with the housing longitudinal axis and the inhaler longitudinal axis. At least about 50%, or at least about 75% of the length of the housing can be coextensive with the length of the inhaler when the inhaler article is received in the holder.

The holder may be formed by an insert molding technique. The penetrating element can be formed, for example, first by molding, and then the housing can be molded around the penetrating element which is joined to the penetrating element. The penetrating element may be a metal penetrating element and the housing may be molded around the metal penetrating element securing the metal penetrating element to the housing. The metal piercing element may include a protrusion or recess at the distal end of the piercing element to increase the surface area of the distal end of the piercing element and to improve fixation within the housing molding material.

The inhaler system may be used by a consumer, such as smoking a conventional cigarette or vaping an e-cigarette. Such smoking or vaping may be characterized by two stages: a first stage, while a small volume containing the total amount of nicotine desired by the consumer is inhaled into the oral cavity, followed by an aerosol containing the desired amount of nicotine The second stage, during which this small volume of the lungs is further diluted with fresh air and aspirated deeper into the lungs. Both stages are controlled by the consumer. During the first inhalation phase the consumer can determine the amount of nicotine to inhale. During the second phase, the consumer can determine the volume to dilute the first volume to be aspirated deep into the lungs, thereby maximizing the concentration of active agent delivered to the airway epithelial surface. This smoking mechanism is sometimes referred to as "puff-inhalation-exhalation".

All scientific and technical terms used herein have meanings commonly used in the art unless otherwise specified. Definitions provided herein are intended to facilitate understanding of certain terms frequently used herein.

As used herein, the singular indefinite articles ("a", "an"), and definite articles ("the") include embodiments with consumer objects, unless the content clearly dictates otherwise.

As used herein, “or” is generally used in its sense including “and/or” unless the context clearly dictates otherwise. The term “and/or” means one or all of the listed elements, or a combination of any two or more of the listed elements.

As used herein, “have”, “having”, “include”, “including”, “comprise”, “comprising”, etc. are open-ended. used in that sense, and generally means "including, but not limited to". It will be understood that "consisting essentially of," "consisting of," and the like are included in "comprising" and the like.

The words “preferred” and “preferably” refer to embodiments of the invention that may provide certain advantages under certain circumstances. However, other embodiments may also be preferred under the same or different conditions. Further, recitation of one or more preferred embodiments does not imply that other embodiments are not useful, and is not intended to exclude other embodiments from the scope of the disclosure, including the claims.

The invention will now be further described with reference to the drawings:
1 is a cross-sectional schematic view of an exemplary inhaler article.
2 is a schematic front view of an exemplary membrane.
3 is a top view of an exemplary inhaler system.
4 is a schematic cross-sectional view of the exemplary inhaler system of FIG. 3 ;
5 is a cross-sectional schematic view of another sleeve;
6 is a cross-sectional schematic view of another exemplary sleeve;
7 is a schematic cross-sectional view of the exemplary inhaler article of FIG. 1 received within the sleeve shown in FIG. 6 ;

The schematic diagrams are not necessarily to scale and are provided for purposes of illustration and not limitation. The drawings illustrate one or more aspects described in this disclosure. However, it will be understood that other aspects not shown in the drawings fall within the scope and spirit of the present disclosure.

1 is a cross-sectional schematic view of an exemplary inhaler article 150 . The inhaler article 150 includes a body 151 extending from a mouthpiece end 154 to a distal end 156 along a longitudinal axis of the inhaler article, a capsule cavity 155 and a capsule 160 retained within the capsule cavity 155 . ) is included. The capsule cavity 155 is defined within the body 151 , is bounded downstream by a filter element 157 , and is defined by a tubular element 153 defining a central passageway 152 in fluid communication with the capsule cavity 155 . bordered by the upstream The central passageway 152 defines an air inlet aperture extending from the distal end 156 of the body 151 to the capsule cavity 155 .

The tubular element 153 extends from a first end 148 defining an upstream boundary of the capsule cavity 155 to a second opposing end 149 defining a distal end 156 of the inhaler article body 151 .

In one embodiment, the tubular element 153 is formed from cellulose acetate and may be referred to as a hollow acetate tubular element. The tubular element 153 has an outer diameter of about 7 mm and an inner diameter of about 5.3 mm to about 5.5 mm, such that the central passage has a diameter of about 5.3 mm to about 5.5 mm. The tubular element 153 has a thickness of about 0.5 mm to about 1 mm. The capsule cavity 155 has a length of about 18 mm to about 20 mm and a diameter of an outer diameter of about 7 mm and an inner diameter of about 6 mm to about 6.5 mm. The filter element 157 has a diameter of about 20 mm to about 22 mm in length and an outer diameter of about 7 mm. The paper wrapper 151 joins the tubular element 153 , the capsule cavity 155 , and the filter element 157 in tandem axial alignment. The total length of the exemplary inhaler article 150 is from about 43 mm to about 47 mm, and the outer uniform diameter is about 7.2 mm.

2 is a front schematic view of an exemplary membrane 158 . The illustrated membrane 158 has three intersecting lines of weakness 159 or slits that intersect at the center of the membrane 158 . In one embodiment, the membrane 158 has a disk shape with a diameter of about 7.3 mm. The line of weakness 159 preferably does not extend to the perimeter of the membrane 158 . Membrane 158 may be secured to a second opposing end 149 of a tubular element 153 defining a distal end 156 of the inhaler article body 151 .

The holder described below may be configured to rupture or open the membrane 158 when received into the holder.

3 is a perspective view of an exemplary inhaler system 100 . 4 is a cross-sectional schematic view of the exemplary inhaler system 100 of FIG. 3 . 5 is a cross-sectional schematic view of an exemplary sleeve 120 . 6 is a cross-sectional schematic view of another exemplary sleeve 120 .

The inhaler system 100 includes an inhaler article 150 and a separate holder 110 . The inhaler article 150 may be received within the holder 110 to activate or penetrate a capsule 160 disposed within the inhaler article 150 . The inhaler article 150 may be held in the holder 110 during use by a consumer. The holder 110 is configured to induce a vortex suction airflow entering the contained inhaler article 150 .

The inhaler system 100 includes an inhaler article 150 and a holder 110 . The inhaler article 150 includes a body 151 extending along an inhaler longitudinal axis L _A . The holder 110 includes a movable sleeve 120 that holds the inhaler article 150 received within the sleeve cavity 122 .

The holder 110 for the inhaler article 150 includes a housing 111 including a housing cavity 112 for receiving the inhaler article 150 and a sleeve configured to hold the inhaler article 150 within the housing cavity 112 ( 120). The sleeve 120 defines a sleeve cavity 122 and is movable within the housing cavity 112 along a longitudinal axis L _A of the housing 111 . The sleeve 120 includes a first end 124 and a second opposing end 126 . The second opposite end 126 of the sleeve 120 is configured to allow air to enter the sleeve cavity 122 . The second opposite end 126 of the sleeve 120 is configured to induce a vortex in the air entering the sleeve cavity 122 .

The holder 110 may include a piercing element 101 secured to and extending from the housing interior surface 109 . The piercing element 101 may be configured to extend through the second opposed end 126 of the sleeve 120 along the longitudinal axis of the housing 111 into the sleeve cavity 122 . The holder 110 may include a spring element 102 configured to bias the sleeve 120 away from the piercing element 101 .

The sleeve 120 may include an elongate slot 128 (see FIG. 5 ) extending along a longitudinal length of the sleeve 120 . Housing 111 may further include pins 127 extending from interior surface 109 of housing cavity 112 . Pin 127 may be configured to engage elongate slot 128 .

5 is a cross-sectional schematic view of an exemplary sleeve 120 . A second opposing end 126 of the sleeve 120 includes a sleeve tubular element 130 defining a central passageway 132 , an end surface 136 and an open end 134 . The central passageway 132 is in fluid communication with the sleeve cavity 122 .

The distal end 156 of the inhaler article 150 (when received within the sleeve 120 ) abuts the central passageway 132 of the sleeve tubular element 130 at the open end 134 . The intake air inlet 138 enters the sleeve tubular element 130 at a tangent to the sleeve tubular element 130 and forms a vortex intake airflow into the central passageway 152 of the received inhaler article 150 tubular element 153 . do. The vortex inhalation airflow flows downstream of the capsule cavity 155 along the central passageway 152 of the tubular element 153 of the contained inhaler article 150 to induce capsule rotation and release particles into the inhalation airflow.

The sleeve 120 defines a first air inlet region 170 that includes at least one air aperture 129 through the sleeve 120 . The first air inlet region 170 is proximate to the first open end 124 of the sleeve 120 . The first air inlet region 170 is configured to allow air to flow into an airflow channel formed between the sleeve 120 and the housing 111 . The sleeve includes a second air inlet section 180 downstream from the first air inlet section 170 . The second air inlet region 180 includes a second opposed end 126 of the sleeve 120 configured to allow air to enter the sleeve cavity 122 . The second air inlet region 180 includes at least one air aperture or air inlet 138 through the sleeve 120 and into the sleeve tubular element 130 having a central passageway 132 .

6 is a cross-sectional schematic view of another exemplary sleeve 120 . A second opposing end 126 of the sleeve 120 includes a sleeve tubular element 130 defining a central passageway 132 , an end surface 136 and an open end 134 . The central passageway 132 is in fluid communication with the sleeve cavity 122 . The sleeve tubular element 130 open end 132 may extend into the sleeve cavity 122 . The sleeve tubular element 130 includes at least one air inlet 138 that allows air to enter into the central passageway 132 . At least one air inlet 138 extends in a direction tangential to the central passageway 132 .

The distal end 156 of the inhaler article 150 may be slid over the sleeve tubular element 130 as shown in FIG. 7 . When the membrane 158 is secured to the distal end 156 of the inhaler article 150 , the sleeve tubular element 130 open end 134 is the inhaler article 150 tubular element 153 in which the sleeve tubular element 130 is received. ) deform the membrane 158 so that it extends into and is pressed through.

Upon insertion of the inhaler article 150 into the holder 110 , the sleeve tubular element 130 open end 134 extends into a membrane 158 such that the sleeve tubular element 130 extends into the inhaler article 150 tubular element 153 in which the sleeve tubular element 130 is received. ) and deformed and pressed through it. Membrane 158 can be biased towards a longitudinal axis of the inhaler article such that inhaler article 150 is gripped onto the holder, thus holding inhaler article 150 in place within holder 110 .

The intake air inlet 138 enters the sleeve tubular element 130 at a tangent to the central passageway 132 and forms a vortex intake airflow into the central passageway 152 of the received inhaler article 150 tubular element 153 . . The vortex intake airflow flows along the central passageway 152 of the tubular element 153 of the contained inhaler article 150 downstream of the capsule cavity to induce capsule rotation and release particles into the intake airstream.

The sleeve tubular element 130 extends into the sleeve cavity 122 and may form an annular recess 131 with the sleeve cavity 122 configured to receive the distal end 156 of the inhaler article 150 . The projection formed by the sleeve tubular element 130 slides into the inhaler article 150 tubular element 153 . The sleeve tubular element 130 is configured herein to extend into the distal end 156 of the inhaler article 150 received within the sleeve cavity 122 .

The sleeve tubular element 130 extends into the sleeve cavity 122 of about 5 mm and may have an outer diameter of about 5.5 mm and an inner diameter of about 4 mm. The central passageway 152 of the tubular element 153 of the received inhaler article 150 may have an inner diameter of about 5.5 mm to provide an interference fit with the sleeve tubular element 130 and the annular recess 131 .

7 is a schematic cross-sectional view of an exemplary inhaler article 150 received within the sleeve 120 shown in FIG. 6 . 7 , the central passageway 152 of the tubular element 153 of the inhaler article 150 aligns with and extends into engagement with the central passageway 132 of the sleeve tubular element 130 .

Claims (16)

An inhaler article comprising:
a body extending along a longitudinal axis of the inhaler article from a mouthpiece end to a distal end;
a capsule cavity defined within the body and bounded downstream by a filter element and upstream bounded by a tubular element defining a central passageway in fluid communication with the capsule cavity, the central passageway along a longitudinal axis of the inhaler article and the a capsule cavity defining an air inlet aperture extending from the distal end of the body towards the capsule cavity, the tubular element having a central passage inner diameter in a range of about 50% to about 90% of the inner diameter of the capsule cavity;
a capsule disposed within the capsule cavity;
and the inhaler article is configured to receive a vortex intake airflow into the central passageway. The inhaler article of claim 1 , wherein the tubular element has a central passageway inner diameter ranging from about 70% to about 90% of the inner diameter of the capsule cavity. 3. The inhaler article according to claim 1 or 2, wherein the tubular element is formed of a cellulosic material. 4. The inhaler article according to any one of claims 1 to 3, wherein the tubular element is formed of cellulose acetate. 5. The inhaler article according to any one of the preceding claims, wherein the tubular element is formed of a biodegradable resin material, preferably a polylactic acid material. The inhaler according to claim 1 , wherein the tubular element extends from a first end defining an upstream boundary of the capsule cavity to a second opposite end defining a distal end of the inhaler article body. article. 7. The inhaler article of claim 6, further comprising a membrane secured to the second opposite end of the tubular element. 8. The inhaler article of claim 7, wherein the membrane comprises at least two slits or lines of weakness. 9. The inhaler article of claim 7 or 8, wherein the membrane is disc-shaped. 10. The inhaler article of any preceding claim, wherein a wrapping layer joins the filter element, the capsule cavity, and the tubular element with a serial axial abutment. 11. An inhaler article according to any one of the preceding claims, wherein the capsule comprises pharmaceutically active particles. An inhaler system comprising:
12. An inhaler article according to any one of claims 1 to 11; and
an inhaler system comprising a holder for the inhaler article, the holder comprising a housing comprising a housing cavity, the holder configured to provide a swirling or rotating inhalation airflow to the inhaler article. 13. The device of claim 12, wherein the holder comprises a sleeve configured to retain the inhaler article within the housing cavity, the sleeve comprising a sleeve cavity and movable within the housing cavity along a longitudinal axis of the housing; the sleeve includes a first open end and a second opposing end, the second opposing end of the sleeve being configured to allow air to enter the sleeve cavity;
The second opposite end of the sleeve includes a sleeve tubular element extending into the sleeve cavity, the sleeve tubular element extending into the tubular element of the inhaler article and configured to secure the inhaler article within the sleeve. . 14. The inhaler system of claim 13, wherein the sleeve tubular element defines an upstream boundary of the capsule cavity when the inhaler article is received within the sleeve cavity. 15. The holder according to claim 13 or 14, wherein the holder further comprises a piercing element secured to and extending from the holder housing inner surface, the piercing element extending along a longitudinal axis of the housing through a second opposite end of the sleeve. an inhaler system extending into the sleeve cavity and configured to activate the capsule. 16. The inhaler system of any of claims 13-15, wherein the second opposite end of the sleeve is configured to induce a vortex or rotational airflow in the intake airflow entering the capsule cavity.

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